Clinical Trial to Evaluate the Efficacy and Safety of JP-1366 in Patients With Gastric Ulcer
- Conditions
- Gastric Ulcer
- Registration Number
- NCT05448001
- Lead Sponsor
- Onconic Therapeutics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 329
Inclusion Criteria: Subjects who meet all of the following criteria can participate<br> in this study:<br><br> 1. Male or female, = 19 years of age at the time of obtaining consent<br><br> 2. Confirmation via upper gastrointestinal endoscopy within 14 days from Visit 2<br> for the following:<br><br> º One or more GUs with the largest ulcer = 3 mm to = 30 mm<br><br> º Largest ulcer classified as A1 or A2 based on Sakita-Miwa classification<br><br> 3. Subjects who fully understand this study and voluntarily signed the informed<br> consent form<br><br> - Exclusion Criteria: Subjects who meet any of the following criteria cannot<br> participate in this trial:<br><br>[Medical History]<br><br> 1. Subjects who have undergone gastric acid secretion suppression surgery, gastric<br> surgery (e.g., gastrectomy and gastromucosectomy), resection of entire small bowel<br> (excluding simple ulcer closure and endoscopic benign tumor resection) or esophageal<br> surgery<br><br> 2. Subjects with history of Zollinger-Ellison syndrome or gastric hypersecretion<br><br> 3. Subjects with hypersensitivity (present or past) to any substance in the IP, drugs<br> in the same class as them (potassium-competitive acid blocker [P-CAB] and proton<br> pump ingibitor[PPI]), or benzimidazole<br><br> 4. Subjects with genetic problems such as galactose intolerance, Lapp lactase<br> deficiency, or glucose-galactose malabsorption<br><br> 5. Subjects with malignant gastrointestinal cancer regardless of the period, Subjects<br> with a history of malignancy within 5 years from Visit 1 (however, subjects with<br> basal cell carcinoma or squamous cell carcinoma who require steady long-term<br> follow-up only without therapeutic dosing/procedure/surgery, etc. can participate in<br> this trial)<br><br> 6. Subjects with a history of drug or alcohol abuse within 1 year from Visit 1.<br><br> 7. Subjects who have had or are scheduled to have major surgery that may affect gastric<br> acid secretion within 30 days from Visit 1<br><br> [Comorbidity]<br><br> 8. Subjects with gastrointestinal bleeding, esophageal stricture, ulcer-induced<br> stenosis, pyloric stenosis, gastroesophageal varices, Barrett's esophagus (> 3 cm),<br> esophageal dysplasia, duodenal ulcer, glandular ulcer, refractory ulcer, perforation<br> ulcer, or surgery-induced ulcer at Visit 1<br><br> 9. Subjects with signal symptoms (dysphagia, severe dysphagia, bleeding, weight loss,<br> anemia, and bloody stools) that suggest malignant tumors of gastrointestinal tract<br> at Visit 1 (except a tumor confirmed negative in endoscopy, etc.)<br><br> 10. Subjects with pancreatitis, inflammatory bowel Disease (Crohn's disease, ulcerative<br> colitis, or Behcet's enteritis) at Visit 1<br><br> 11. Subjects with known acquired immune deficiency syndrome (AIDS) or hepatitis<br> (including Hepatitis B surface (HBs) antigen positive, Hepatitis C virus (HCV)<br> antibody positive, or hepatitis virus carrier) (except subjects that are HCV-RNA<br> negative)<br><br> 12. Subject with clinically significant mental illness<br><br> 13. Thrombotic patients (cerebral thrombosis, myocardial infarction, thrombophlebitis,<br> etc.)<br><br> 14. Subjects who confirmed malignant tumors by upper gastrointestinal endoscopy during<br> the Screening (Visit 1). If a biopsy is required. Subject who may have an impact on<br> the lesion evaluated in this clinical trial needs to be excluded, and the biopsy<br> should not be delayed for registration in this clinical trial.<br><br> [Drug Dosing/Treatment History]<br><br> 15. Subjects with a history of taking any of the following drugs or those required to<br> take them until the end of treatment (EOT): For participation in this trial, stable<br> drugs must not be discontinued.:<br><br> <Drugs prohibited from within 2 weeks of Visit 1 to EOT><br><br> º All acid blockers other than the IPs: H2 receptor antagonists, proton pump<br> inhibitors (PPIs) and potassium-competitive gastric acid blockers<br><br> º Gastromucosal protection agents: Prostaglandins (however, local administration is<br> allowed) and mucosal blood flow stimulants Antacids<br><br> º Gastrointestinal motility stimulants<br><br> º Anticholinergics (however, local administration is allowed)<br><br> º Cholinergic agents (however, local administration is allowed)<br><br> º Glucocorticosteroids (however, local administration is allowed)<br><br> º Gastrin receptor antagonist, other drugs for the treatment of peptic ulcer<br><br> <Drugs prohibited from Visit 1 to EOT><br><br> º Rilpivirine, atazanavir, and nelfinavir<br><br> º Antipsychotics, antidepressants, and antianxiety drugs<br><br> <1 week prior to the date of upper gastrointestinal endoscopy(EGD)><br><br> º Non-steroidal anti-inflammatory drugs (NSAIDs)<br><br> º Antithrombotic agents: Anticoagulants or antiplatelet drugs<br><br> However, among the above drugs, drugs administered as a pre-treatment for upper<br> gastrointestinal endoscopy or for an urea breath test are allowed<br><br> : midazolam, propofol, simethicone, hyoscine butylbromide, cimetropium bromide,<br> magmil, pethidine, gasocol, urea, etc.<br><br> 16. Subjects who have participated in another clinical trial within 4 weeks from Visit 1<br> and have been administered with or used an IP or medical device at least once<br><br> 17. Subjects who have received H.pylori eradication treatment within 4 weeksfrom the<br> date of upper gastrointestinal endoscopy.<br><br> 18. Subjects who have clinically significant abnormal electrocardiogram<br><br> [Laboratory Tests]<br><br> 19. Blood test results meet the criteria below at Visit 1:<br><br> º ALT, AST, ALP, GGT, Total bilirubin > 2.0 x ULN<br><br> º eGFR < 60 mL/min/1.73 m2<br><br> [Other]<br><br> 20. Subjects who cannot undergo upper gastrointestinal endoscopy<br><br> 21. Pregnant or breast-feeding women<br><br> 22. Women and men of childbearing potential who are unwilling to use an appropriate<br> medically acceptable method of contraception during the entire study period (Visit 1<br> through the end of study visit)<br><br> 23. Subjects who are judged unsuitable for participation in this trial by the<br> investigators for other reasons
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cumulative complete healing rate for ulcer confirmed by upper gastrointestinal endoscopy by Week 8
- Secondary Outcome Measures
Name Time Method Complete healing rate for ulcers confirmed by upper gastrointestinal endoscopy at Week 4;Complete healing rate for ulcer confirmed by upper gastrointestinal endoscopy at Week 4 by Helicobacter pylori infection status;Cumulative complete healing rate for ulcer confirmed by upper gastrointestinal endoscopy according to Helicobacter pylori infection status by Week 8;Changes of Gastrointestinal symptoms per NDI-K at week 4 and 8;Changes in quality of life (EQ-5D-5L) at Weeks 4 and 8;Changes and the proportion of changes of the ulcer size(s) at week 4 and week 8;Change of the number of ulcer(s) at week 4 and week 8